NF EN ISO 10993-23

NF EN ISO 10993-23

March 2021
Standard Current

Biological evaluation of medical devices - Part 23 : tests for irritation

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2.This document includes:— pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;— details of in vitro and in vivo irritation test procedures;— key factors for the interpretation of the results.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

March 2021

Number of pages

77 p.

Reference

NF EN ISO 10993-23

ICS Codes

11.100.20   Biological evaluation of medical devices
11.040.01   Medical equipment in general

Classification index

S99-501-23

Print number

1

International kinship

ISO 10993-23:2021

European kinship

EN ISO 10993-23:2021
Sumary
Biological evaluation of medical devices - Part 23 : tests for irritation

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑2.

This document includes:

— pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;

— details of in vitro and in vivo irritation test procedures;

— key factors for the interpretation of the results.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Principes généraux - Approche par étapes
  • 5 Considérations préalables aux essais
  • 6 Essais d'irritation in vitro
  • 7 Essais d'irritation in vivo
  • 8 Essai d'irritation de la peau sur l'homme
  • Annexe A (normative) Préparation des matériaux pour les essais d'irritation
  • Annexe D (normative) Essais d'irritation particuliers
  • Annexe E (normative) Essai d'irritation de la peau humaine
  • Annexe B (informative) Liste de contrôle de la méthode d'essai pour les essais d'irritationin vitroutilisant des modèles d'épiderme humain reconstruit
  • Annexe C (informative) Exemple de Fiche de documentation de la méthode pour les modèles d'épiderme humain reconstruit
  • Annexe F (informative) Informations générales sur les essais d'irritation
  • Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive européenne 93/42/CEE [JO L 169]
  • Annexe ZB (informative) Relation entre la présente Norme européenne et les exigences essentielles concernées de la Directive européenne 90/385/CEE [JO L 189]
  • Annexe ZC (informative) Relation entre la présente Norme européenne et les exigences générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/745
  • Bibliographie
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ